Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:33 PM
Study NCT ID:
NCT07395518
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-09
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a randomized controlled trial (RCT) in which participants are divided into two groups:\n\nBlock randomization will be used, employing a block size of four to ensure a balanced number of participants in both groups.\n\nIntervention Group: Pregnant women undergoing cesarean section with placement of a subcutaneous wound drain.\n\nControl Group: Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-01', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-02-01', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': '14 days', 'description': 'To compare the incidence of surgical site infection after cesarean section in pregnant women with and without subcutaneous wound drainage.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '14 days', 'description': 'Length of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean section wound infection', 'Subcutaneous incision drainage', 'Elective and Emergency Cesarean section wound infection.'], 'conditions': ['Surgical Site Infection (SSI)']}, 'descriptionModule': {'briefSummary': 'To study and compare the incidence of surgical site infection after cesarean section in pregnant women with subcutaneous wound drainage and those without subcutaneous wound drainage at Queen Savang Vadhana Memorial Hospital, Sriracha. Chonburi Thailand', 'detailedDescription': 'This study is a randomized controlled trial (RCT) designed to compare the incidence of surgical site infection after cesarean section between patients who receive subcutaneous wound drainage (Radivac drain) and those who do not. Postoperative wound follow-up will be conducted on postoperative days 3, 7, and 14.\n\nParticipants will be randomly assigned into two groups, with the control group consisting of pregnant women undergoing cesarean section at Queen Savang Vadhana Memorial Hospital, Sriracha. Data will be collected on surgical site infection, pain, postoperative complications, and length of hospital stay.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to communicate in Thai\n* Undergoing cesarean section, both elective and emergency procedures\n* Subcutaneous fat thickness ≥ 4 cm, measured preoperatively using a standardized ultrasound technique\n* Able to return for postpartum follow-up at Somdech Phra Boromrajthevi Hospital, Sriracha\n* Willing to participate in the study and able to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women with chronic immunosuppressive conditions, such as systemic lupus erythematosus (SLE), HIV infection, severe anemia (Hb \\< 10.0 g/dL), or uncontrolled diabetes\n* Presence of skin disease or skin infection at the abdominal surgical site\n* Evidence of infection prior to cesarean section\n* Abnormal bleeding disorders requiring specialized treatment\n* History of allergy to, or complications from, the use of wound drainage systems\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07395518', 'briefTitle': 'A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Queen Savang Vadhana Memorial Hospital, Thailand'}, 'officialTitle': 'A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital', 'orgStudyIdInfo': {'id': '014/2568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Pregnant women undergoing cesarean section with placement of a subcutaneous wound drain.', 'interventionNames': ['Device: Radivac drain']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain.'}], 'interventions': [{'name': 'Radivac drain', 'type': 'DEVICE', 'description': 'In the intervention group, a subcutaneous wound drain is placed using a closed suction Redivac drain (10-14 French). The drain is inserted into the subcutaneous layer above the surgical incision through a skin exit site located 2-3 cm from the wound edge, avoiding visible vessels to reduce bleeding. A trocar is used to guide placement, ensuring the drain lies transversely beneath and covers the entire length of the incision. The drain is secured to the skin with silk sutures, connected to a Redivac suction system to apply negative pressure, and covered with a sterile dressing after skin closure to reduce the risk of contamination.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20110', 'city': 'Chon Buri', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Queen Savang vadhana Memmorial Hospital', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data was save in form of microsoft excel spreadsheet and SPSS file'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Savang Vadhana Memorial Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}